Overview
In this role you lead the PV Partnerships and Operations function to ensure compliant, effective pharmacovigilance across partners and vendors. You will align internal and external stakeholders, drive governance, and ensure inspection readiness while advancing product-level safety operations. Your leadership enables scalable PV processes during development, launches, and acquisitions, with a focus on patient safety and cross-functional collaboration. This is a chance to shape global PV delivery in a rare-disease-focused environment.
Leistungen / Benefits
- comprehensive total rewards package
- industry-competitive compensation
- global exposure
- opportunities to contribute to rare diseases
- cross-functional collaboration
- career development and leadership opportunities
Verantwortungsbereiche
- Lead the PV Partnership & Operations function, set strategy, governance, and performance expectations across the team
- Ensure quality, compliance, risk management, and inspection readiness for PV activities with partners
- Develop and manage the PV Partnership team, including recruitment, performance management, and capability building
- Provide PV leadership for new and existing partner collaborations, including alliance governance and PV process alignment
- Oversee case exchange, reconciliation, and adherence to PVAs and SDEAs with internal and external partners
- Coordinate with PV VM and eESPs to address performance and quality concerns and implement corrective actions
- Guide study-level safety management plans and ensure clear roles for case processing and safety reporting
- Oversee collaboration with Clinical Ops, Regulatory Affairs, CROs, and Data Management for safety data transfer and reconciliation
- Prepare and maintain product-level safety information guides and assess PV impact on marketing materials
- Ensure quality and compliance through audits, non-conformances, CAPAs, and inspection readiness
- Manage PV system changes affecting partnerships, vendor operations, and product activities
- Lead PV contributions to M&A activities, system migrations, and data integration across products
Zentrale Anforderungen
- University level qualification in biosciences, healthcare or pharmacy
- At least 10 years of pharmacovigilance experience in the pharmaceutical industry
- Strong experience in case processing, safety data management, and partner/vendor oversight
- Experience leading and developing teams in a complex operational environment
- Solid knowledge of GVP and GCP
- Fluent English, written and spoken
- Effective team leadership and development
- Collaborative problem-solving
- Strong communication and relationship-building
- GVP and GCP knowledge
- Pharmacovigilance systems and processes
- Vendor management of external partners
Global PV Partnership & Operations Director in Basel Arbeitgeber: Swedish Orphan Biovitrum
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld zu arbeiten, das sich auf den Zugang zu spezialisierten Gesundheitsprodukten konzentriert. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und zum Networking mit verschiedenen Stakeholdern bieten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einer positiven Work-Life-Balance, die es Ihnen ermöglichen, Ihre Karriere und Ihr persönliches Leben in Einklang zu bringen.
